Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis

NCT02638259 | Completed Phase 3 Results DMC

• 1 other identifier: GP15-301
• Study Type: interventional
• Target: 376
• Locations: 15 countries
• Sites: 88

Brief Summary

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).

Conditions

Rheumatoid Arthritis

Keywords

Biosimilars; Rheumatoid Arthritis; Etanercept

Outcome Measures

Primary Outcomes (1)

• Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel

  Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity, values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \< 2.6 corresponds to remission DAS28-CRP = 0.56 \* sqrt(tender28) + 0.28\* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* GDA + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm

  treatment period 1: up to 24 weeks

Secondary Outcomes (32)

• Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel

  Treatment Period 1, up to 24 weeks

• Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients

  baseline, week 2, week 4, week 12, week 24

• Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24;

  week 4, 12, 24

• Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24

  baseline, Week 4, week 12, week 24

• Treatment Period 1- Proportion of Patients Achieving EULAR Response

  week 4, week 12 and week 24

Study Arms (2)

50mg GP2015

EXPERIMENTAL

Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).

Drug: GP2015

50mg EU-authorized Enbrel

ACTIVE COMPARATOR

Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).

Drug: GP2015

Interventions

GP2015 DRUG

Enbrel comparator

50mg EU-authorized Enbrel; 50mg GP2015

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria \>/= 6 months at the time of baseline visit
• Patient must have active disease defined as DAS28-CRP\>/=3.2
• Patients must have CRP level above ULN \>5mg/l) or erythrocyte sedimentation rate (ESR) \>/=28mm/h
• Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards

You may not qualify if:

• Previous exposure to etanercept in the past
• Patients with functional status class IV according to the ACR 1991 revised criteria
• History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening

Sponsors & Collaborators

• Sandoz: lead

Study Sites (92)

Novartis Investigative Site

Peoria, Arizona, 85381, United States

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Novartis Investigative Site

Phoenix, Arizona, 85023, United States

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Novartis Investigative Site

El Cajon, California, 92020, United States

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Novartis Investigative Site

Upland, California, 91786, United States

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Novartis Investigative Site

Van Nuys, California, 91405, United States

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Novartis Investigative Site

Trumbull, Connecticut, 06611, United States

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Novartis Investigative Site

Clearwater, Florida, 33765, United States

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Novartis Investigative Site

Gainesville, Florida, 32607, United States

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Novartis Investigative Site

Miami, Florida, 33135, United States

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Novartis Investigative Site

Miami, Florida, 33169, United States

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Novartis Investigative Site

Orlando, Florida, 32804, United States

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Novartis Investigative Site

Tampa, Florida, 33603, United States

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Novartis Investigative Site

Zephyrhills, Florida, 33542, United States

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Novartis Investigative Site

Lexington, Kentucky, 40615, United States

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Monroe, Louisiana, 71203, United States

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Novartis Investigative Site

Frederick, Maryland, 21702, United States

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Novartis Investigative Site

St Louis, Missouri, 63128, United States

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Novartis Investigative Site

Orchard Park, New York, 14127, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28210, United States

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Novartis Investigative Site

Cincinnati, Ohio, 45219, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73112, United States

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Novartis Investigative Site

Rapid City, South Dakota, 57701, United States

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Novartis Investigative Site

Austin, Texas, 78731, United States

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Novartis Investigative Site

Carrollton, Texas, 75007, United States

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Novartis Investigative Site

Spokane, Washington, 99204, United States

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Novartis Investigative Site

Plovdiv, 4000, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Sofia, 1505, Bulgaria

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Novartis Investigative Site

Sofia, 1784, Bulgaria

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Novartis Investigative Site

Varna, 9010, Bulgaria

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Novartis Investigative Site

Pardubice, Czech Republic, 53002, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 148 00, Czechia

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Novartis Investigative Site

Prague, 128 50, Czechia

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Novartis Investigative Site

Prague, 140 00, Czechia

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Novartis Investigative Site

Prague, 140 59, Czechia

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Novartis Investigative Site

Zlín, 760 01, Czechia

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Novartis Investigative Site

Tallinn, 10117, Estonia

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Novartis Investigative Site

Tallinn, 13419, Estonia

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Novartis Investigative Site

Tartu, 50107, Estonia

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Novartis Investigative Site

Tartu, EE-50106, Estonia

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Novartis Investigative Site

Berlin, 12161, Germany

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Magdeburg, 39112, Germany

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München, 80336, Germany

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Békéscsaba, H-5600, Hungary

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Budapest, 1036, Hungary

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Szentes, 6600, Hungary

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Szolnok, H-5000, Hungary

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Novartis Investigative Site

Florence, FI, 50139, Italy

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Novartis Investigative Site

Rozzano, MI, 20089, Italy

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Novartis Investigative Site

Liepāja, LV 3401, Latvia

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Novartis Investigative Site

Riga, LV-1038, Latvia

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Novartis Investigative Site

Riga, LV-1050, Latvia

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Novartis Investigative Site

Klaipėda, Klaipėda County, 92288, Lithuania

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Novartis Investigative Site

Kaunas, LTU, LT-50161, Lithuania

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Novartis Investigative Site

Panevezys, LT-35144, Lithuania

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Novartis Investigative Site

Vilnius, LT 08661, Lithuania

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Novartis Investigative Site

Guadalajara, Jalisco, 44160, Mexico

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Novartis Investigative Site

San Luis Potosí City, San Luis Potosí, 78240, Mexico

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Novartis Investigative Site

Mérida, Yucatán, 97070, Mexico

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Novartis Investigative Site

Querétaro City, 76178, Mexico

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Poznan, Greater Poland Voivodeship, 61-397, Poland

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Lublin, Lublin Voivodeship, 20-582, Poland

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Novartis Investigative Site

Elblag, 82-300, Poland

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Novartis Investigative Site

Nadarzyn, 05-830, Poland

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Novartis Investigative Site

Warsaw, 01518, Poland

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Novartis Investigative Site

Warsaw, 02 106, Poland

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Novartis Investigative Site

Warsaw, 02 118, Poland

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Novartis Investigative Site

Warsaw, 02 691, Poland

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Novartis Investigative Site

Wroclaw, 53-224, Poland

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Novartis Investigative Site

Moscow, 109240, Russia

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Novartis Investigative Site

Petrozavodsk, 185019, Russia

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Novartis Investigative Site

Saint Petersburg, 190068, Russia

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Novartis Investigative Site

Saratov, 410028, Russia

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Novartis Investigative Site

Smolensk, 214025, Russia

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Novartis Investigative Site

Voronezh, 394036, Russia

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Novartis Investigative Site

Yaroslavl, 150003, Russia

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Novartis Investigative Site

Yekaterinburg, 620028, Russia

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Novartis Investigative Site

Belgrade, 11000, Serbia

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Novartis Investigative Site

Bratislava, 84103, Slovakia

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Novartis Investigative Site

Poprad, 058 01, Slovakia

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Novartis Investigative Site

Rimavská Sobota, 979 01, Slovakia

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Novartis Investigative Site

Zvolen, 960 01, Slovakia

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Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

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Novartis Investigative Site

Seville, Andalusia, 41009, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

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Novartis Investigative Site

Valencia, Valencia, 46017, Spain

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Novartis Investigative Site

Córdoba, 14004, Spain

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Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

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Novartis Investigative Site

Leeds, West Yorkshire, LS7 4SA, United Kingdom

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Novartis Investigative Site

Edinburgh, EH4 2XU, United Kingdom

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Novartis Investigative Site

London, NW3 2QG, United Kingdom

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Related Publications (3)

• Thaci D, Gerdes S, Schulze-Koops H, Allanore Y, Kavanaugh A, Both C, Gattu S, Hachaichi S, Matucci-Cerinic M. Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA). Drugs R D. 2025 Jun;25(2):107-115. doi: 10.1007/s40268-025-00507-8. Epub 2025 Apr 25.

  PMID: 40279006 DERIVED

• Jaworski J, Matucci-Cerinic M, Schulze-Koops H, Buch MH, Kucharz EJ, Allanore Y, Kavanaugh A, Young P, Babic G. Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study. Arthritis Res Ther. 2019 May 28;21(1):130. doi: 10.1186/s13075-019-1907-x.

  PMID: 31138316 DERIVED

• Matucci-Cerinic M, Allanore Y, Kavanaugh A, Buch MH, Schulze-Koops H, Kucharz EJ, Woehling H, Babic G, Poetzl J, Davis A, Schwebig A. Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study. RMD Open. 2018 Nov 14;4(2):e000757. doi: 10.1136/rmdopen-2018-000757. eCollection 2018.

  PMID: 30487998 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GP2015

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Sandoz Biopharma Clinical Development - Strategic Planning
• Organization: Sandoz

biopharma.clinicaltrials@sandoz.com

0049(0)80244760

Study Officials

• Arnd Schwebig, MD

  Global Program Medical Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 23, 2015
• Study Start: February 21, 2015
• Primary Completion: December 29, 2016
• Study Completion: June 12, 2017
• Last Updated: September 19, 2018
• Results First Posted: February 23, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); ME (4); BU (5); CZ (6); SE (1); SL (4); PL (9); HU (4); LI (4); DE (3); IT (2); RU (8); GB (4); LA (3); US (26)